PMID- 21098150
OWN - NLM
STAT- MEDLINE
DCOM- 20110208
LR  - 20210318
IS  - 1098-4275 (Electronic)
IS  - 0031-4005 (Linking)
VI  - 126
IP  - 6
DP  - 2010 Dec
TI  - Adverse events from cough and cold medications after a market withdrawal of 
      products labeled for infants.
PG  - 1100-7
LID - 10.1542/peds.2010-1839 [doi]
AB  - OBJECTIVE: A voluntary market withdrawal of orally administered, 
      over-the-counter, infant cough and cold medications (CCMs) was announced in 
      October 2007. The goal of this study was to assess CCM-related adverse events 
      (AEs) among children after the withdrawal. METHODS: Emergency department (ED) 
      visits for CCM-related AEs among children <12 years of age were identified from a 
      nationally representative, stratified, probability sample of 63 US EDs, for the 
      14 months before and after announcement of withdrawal. RESULTS: After withdrawal, 
      the number and proportion of estimated ED visits for CCM-related AEs involving 
      children <2 years of age were less than one-half of those in the prewithdrawal 
      period (1248 visits [13.3%] vs 2790 visits [28.7%]; difference: -15.4% [95% 
      confidence interval [CI]: -25.9% to -5.0%]), whereas the overall number of 
      estimated ED visits for CCM-related AEs for children <12 years of age remained 
      unchanged (9408 visits [95% CI: 6874-11 941 visits] vs 9727 visits [95% CI: 
      6649-12 805 visits]). During both periods, two-thirds of estimated ED visits 
      involved unsupervised ingestions (ie, children finding and ingesting 
      medications). CONCLUSIONS: ED visits for CCM-related AEs among children <2 years 
      of age were substantially reduced after withdrawal of over-the-counter infant 
      CCMs. Further reductions likely will require packaging improvements to reduce 
      harm from unsupervised ingestions and continued education about avoiding CCM use 
      for young children. Monitoring of CCM-related harm should continue because 
      recommendations were updated in October 2008 to avoid the use of CCMs for 
      children <4 years of age.
FAU - Shehab, Nadine
AU  - Shehab N
AD  - Division of Healthcare Quality Promotion, National Center for Emerging and 
      Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 
      Clifton Rd, NE, Mailstop A-24, Atlanta, GA 30333, USA.
FAU - Schaefer, Melissa K
AU  - Schaefer MK
FAU - Kegler, Scott R
AU  - Kegler SR
FAU - Budnitz, Daniel S
AU  - Budnitz DS
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
DEP - 20101122
PL  - United States
TA  - Pediatrics
JT  - Pediatrics
JID - 0376422
RN  - 0 (Antitussive Agents)
RN  - 0 (Expectorants)
RN  - 0 (Nasal Decongestants)
RN  - 0 (Nonprescription Drugs)
SB  - IM
MH  - Antitussive Agents/*pharmacology
MH  - Child
MH  - Child, Preschool
MH  - Common Cold/complications/*drug therapy
MH  - Cough/*drug therapy/etiology
MH  - *Drug Labeling
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Expectorants/*pharmacology
MH  - Female
MH  - Humans
MH  - Male
MH  - Nasal Decongestants/*pharmacology
MH  - Nonprescription Drugs/pharmacology
MH  - *Product Recalls and Withdrawals
EDAT- 2010/11/26 06:00
MHDA- 2011/02/09 06:00
CRDT- 2010/11/25 06:00
PHST- 2010/11/25 06:00 [entrez]
PHST- 2010/11/26 06:00 [pubmed]
PHST- 2011/02/09 06:00 [medline]
AID - peds.2010-1839 [pii]
AID - 10.1542/peds.2010-1839 [doi]
PST - ppublish
SO  - Pediatrics. 2010 Dec;126(6):1100-7. doi: 10.1542/peds.2010-1839. Epub 2010 Nov 
      22.